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Specifically, the agency is allowing certain dry heat systems to be used on authorized FFRs that do not have exhalation valves, do not use a duck-bill design and do not contain antimicrobial or antiviral agents. Read More
The new regulation goes into effect on May 26, 2022, except for in vitro diagnostics that qualify for a grace implementation period that extends to May 27, 2024. Read More
“Of serious concern is the fact that around 18 months away from IVDR date of application, the specific Class D conformity assessment infrastructure is limited or missing altogether,” MedTech Europe said. Read More
A draft FDA guidance recommends sponsors of medical devices that are electrically powered or have electronic circuitry provide 11 categories of safety information in their premarket submissions. Read More
As part of its vast overhaul of its drugs and devices regulatory system, China has been placing a heavy emphasis on postmarket surveillance over the last two years. Read More
The EU’s implementation of the new In Vitro Medical Device Regulation (IVDR) “has ground to a halt in the wake of the COVID-19 outbreak,” MedTech Europe said, pressing the European Commission for help with the transition process for high-risk devices. Read More
The guidance explains how UV equipment should be used to decontaminate single-use devices and on soft surfaces, such as on personal protective equipment. Read More
Unless a specific exemption, approval or authority applies, devices must be entered in the ARTG before they can be sold in Australia, the agency said. Read More